Methods and systems for managing patient treatment compliance

ABSTRACT

Provided are computer implemented method and systems for providing and monitoring patient compliance with a patient healthcare treatment plan. The method includes receiving, from a healthcare provider over a network, application features for generating a patient application including patient instructions for using a medical therapy, and generating an application for a patient. The application includes at least an input for the user to input data for use in evaluating patient compliance with a treatment plan. In addition, the method includes receiving, from the healthcare provider over the network, a prescription for the application for the patient, and activating the application after the patient receives training on use of the application. The method also may include receiving patient compliance data from the application over the network based on the input.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/161,092, filed Jan. 28, 2021; which is a continuation of U.S.application Ser. No. 17/074,442, filed Oct. 19, 2020, now U.S. Pat. No.10,937,535 issued Mar. 2, 2021; which is a continuation of U.S.application Ser. No. 15/839,446, filed Dec. 12, 2017, now U.S. Pat. No.10,839,951 issued Nov. 17, 2020; which is a continuation of U.S.application Ser. No. 14/516,015, filed Oct. 16, 2014, now U.S. Pat. No.9,881,136 issued Jan. 30, 2018; which claims priority to U.S.Provisional Application No. 61/892,151, entitled “Methods and Systemsfor Managing Patient Treatment Compliance”, filed Oct. 17, 2013, theentireties of each of which are incorporated by reference herein.

TECHNICAL FIELD

The present disclosure generally relates to patient monitoring. Morespecifically, the present disclosure relates to methods and systems formonitoring patient behavior and treatment compliance as well as reducingfraud and waste of pharmaceutical and medical products including, e.g.,prescribed therapies.

BACKGROUND

Physicians often ascertain patient compliance with treatmentinstructions after subsequent patient visits and evaluation. In somecases, failure to comply with physician treatment instructions may leadto prolonged patient illness and/or worsened patient health. Inaddition, lack of proper compliance may lead to a waste of medicaldevices, drugs, or other prescribed therapies. This waste, in turn, maylead to increased medical costs, as well as improper feedback of thephysician's treatment plan and/or the efficacy of the prescribedtherapy. Further, patient compliance with physician treatmentinstructions may still fail to provide patients with dynamic informationand assistance with managing their disease.

Accordingly, a need exists for methods and systems for monitoringpatient behavior and treatment, drug and/or therapy usage, compliance,and improved patient compliance.

SUMMARY

Examples of the present disclosure relate to, among other things,patient monitoring. Each of the examples disclosed herein may includeone or more of the features described in connection with any of theother disclosed examples.

In one example, a computer implemented method for providing andmonitoring patient compliance with a patient healthcare treatment planmay include receiving, from a healthcare provider over a network,application features for generating a patient application includingpatient instructions for using a medical therapy. The method also mayinclude generating an application for a patient, the applicationincluding at least an input for the patient to input data for use inevaluating patient compliance with the patient healthcare treatmentplan. The method also may include receiving, from the healthcareprovider over the network, a prescription for the application for thepatient, activating the application after the patient receives at leastone instruction on use of the application, and receiving patientcompliance data from the application over the network based on theinput.

Examples of the method may include one or more of the followingfeatures: further comprising a step of providing, via the network, anotification to a dispenser to refill a patient prescription for themedical therapy based on the patient compliance data; the step ofactivating the application may comprise receiving, over the network,instructions from a patient's insurance company; the method may furtherinclude sending, via the network, a report to the healthcare provider,based on the patient compliance data; wherein the step of generating theapplication for the patient comprises electronically acquiring anational drug code number from a regulatory entity; wherein the step ofreceiving patient compliance data may include automatically updating theapplication based on electronic feedback; wherein the at least oneinstruction may be conducted online; wherein the step of receiving theapplication features for generating a patient application may includeproviding access to an electronic medical record of the patient; furthercomprising generating a medical profile of the patient based on parsingthe electronic medical record of the patient; and further comprisinggenerating electronic feedback to the patient based on electronicprocessing of the compliance data.

In another example, a system for providing and monitoring compliancewith a patient healthcare treatment plan may include a data storagedevice storing instructions for causing computer servers or mobiledevices to one of generate or provide the patient healthcare treatmentplan and evaluate patient compliance with the patient healthcaretreatment plan. The system also may include a processing deviceconfigured to execute instructions to perform a method of: receiving,from a healthcare provider over a network, application features forgenerating a patient application including patient instructions forusing a medical therapy; generating an application for a patient, theapplication including at least an input for patient to input data foruse in evaluating patient compliance with the patient healthcaretreatment plan; receiving, from the healthcare provider over thenetwork, a prescription for the application for the patient; activatingthe application after the patient receives at least one instruction onuse of the application; and receiving patient compliance data from theapplication over the network based on the input.

In another example, a non-transitory computer-readable medium may beconfigured for storing instructions that, when executed by a processor,cause the processor to provide and monitor compliance with a patienthealthcare treatment plan, the instructions may comprise: receiving,from a healthcare provider over a network, application features forgenerating a patient application including patient instructions forusing medication; generating an application for a patient, theapplication including at least an input for the user to input data foruse in evaluating patient compliance with a treatment plan; receiving,from the healthcare provider over the network, a prescription for theapplication for the patient; and activating the application after thepatient receives training on use of the application; and receivingpatient compliance data from the application over the network.

Additional objects and advantages of the disclosed embodiments will beset forth in part in the description that follows, and in part will beapparent from the description, or may be learned by practice of thedisclosed embodiments. The objects and advantages of the disclosedembodiments will be realized and attained by means of the elements andcombinations particularly pointed out in the appended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the disclosed embodiments

According to some embodiments, disclosed herein is a process that allowshealthcare providers to prescribe computer applications or othersoftware programs/algorithms for behavioral monitoring and treatment oftheir patients.

In one embodiment, the process includes a means where an exemplaryapplication, such as a mobile health (mHealth) application, is used by apatient as part of his/her healthcare treatment plan in order tointroduce proactive thinking into health consciousness of the patient.

In another embodiment, the process may include a means that may allowthe healthcare provider to have an outside system monitor the health oftheir patient and relieve the burden associated with proactive healthcare from healthcare providers.

Still further, the process may include a means where the prescriptionevent (post hoc treatment of symptoms) becomes event-related toproactive treatment and management of patient disease.

In another aspect, it is further contemplated to introduce a mobilehealth (mHealth) application usage as a service to all entities in ahealth care system, including pharmaceutical companies, the healthcareproviders, patients, retailers, pharmacies, and health insurancecompanies.

In another embodiment, it is contemplated to reduce fraud and abuse byintroducing patient compliance with a mobile health (mHealth)application as a parameter for successful treatment of a disease.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a patient monitoring system configured toprovide online monitoring of patient treatment compliance, according toan exemplary embodiment of the present disclosure;

FIG. 2 is a diagrammed series of steps view showing steps of using asystem for prescribing a mobile health application to a patient,according to an exemplary embodiment of the present disclosure;

FIG. 3 is a diagrammed method view showing steps of involving entitiesin a health care system in a mobile health application deployment,according to an exemplary embodiment of the present disclosure;

FIG. 4 is a diagrammed method view showing steps of developing mobileheath application software, according to an exemplary embodiment of thepresent disclosure;

FIG. 5 is a diagrammed method view showing steps of party notificationof usage of the mobile health application, according to an exemplaryembodiment of the present disclosure;

FIG. 6 is a diagrammed method view showing steps of creating apreliminary medical profile of the patient's disease, according to anexemplary embodiment of the present disclosure;

FIG. 7 is a diagrammed method view showing steps of patient interactionswith and management of a disease with the mobile health application,according to an exemplary embodiment of the present disclosure;

FIG. 8 is a diagrammed method view showing steps of the mobile healthsupport system in managing the patient and mobile health applicationusage, according to an exemplary embodiment of the present disclosure;

FIG. 9 is a diagrammed method view showing steps of data transmissionfrom the patient interaction with the mobile health application,according to an exemplary embodiment of the present disclosure;

FIG. 10 is a diagrammed method view showing steps of smart profilebuilding for personalized management of the patient's disease, accordingto an exemplary embodiment of the present disclosure;

FIG. 11 is a diagrammed method view showing steps of prescriptionactivation, according to an exemplary embodiment of the presentdisclosure;

FIG. 12 is a diagrammed method view showing steps of establishingidentifying information that can be used to attribute the mobile healthapplication usage to a patient, according to an exemplary embodiment ofthe present disclosure;

FIG. 13 is a diagrammed method view showing steps of associating patientmonitoring, compliance, and billing, according to an exemplaryembodiment of the present disclosure; and

FIG. 14 is a functional block diagram of a computer that may beconfigured as a host server, for example, to function as a break pointserver.

DETAILED DESCRIPTION

Reference will now be made in detail to the exemplary embodiments of thedisclosure, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

The present disclosure describes systems and methods for monitoring ofpatient behavior and treatment compliance as well as reducing fraud andwaste of pharmaceutical and medical products and/or therapies.

FIG. 1 is a block diagram of a patient monitoring system 100 configuredto provide online monitoring of patient treatment compliance, accordingto an exemplary embodiment of the present disclosure. A patient 8 havingan electronic device 19, such as a mobile device, computer, medicaldevice, or any other electronic device configured to access anelectronic network 32, such as the Internet, may communicate with orotherwise access a mobile health (mHealth) application 1. The mHealthapplication may include patient identifying information, treatmentregimen, information about treatments and healthcare, and any otherrelevant information and may be in communication with other entities ornetworks to send and receive information. A healthcare provider 7, suchas a physician, may prescribe the application. The mHealth application 1may be tailored to a specific patient and may be activated in person bythe patient by visiting a pharmacy 10 or pharmacy practice 9 or otherauthorized entity. The patient 8 may receive training on using themHealth application 1 by a mHealth support system 25 and/or applicationtrainer 24. The mHealth application 1 may include programming 28 ofvarious forms, such as machine learning programming algorithms 26.

The patient treatment plan may include a prescription (e.g. for a drug,device, and/or therapy), which may be dispensed by the pharmacy 9. Thepharmacy 9 may allow the refill of the prescribed product/therapy afterreceiving authorization based on the patient's compliance with his/herhealthcare treatment plan. The authorization may be received by thepharmacy 10 by a communication from the application 1, via the network32 and various servers 29. Use of the drug or other medicalproduct/therapy also may be sent to the manufacturer 37 over the network32 to inform the manufacturer 37 of the amount of medical product ortherapy being used by patient 8. This information may assist themanufacturer 37 in assessing demand and planning supply of the medicalproduct or therapy. The healthcare provider 7 also may receive a reportbased on the patient information received by the application 1, and mayupdate the patient treatment plan based on this information. Thepatient's electronic medical record 14 also may be automaticallyelectronically updated via the network 32 based on the patientinformation, which may include electronically transmitted patientfeedback on the application, received by the mHealth application 1.

Referring now to FIG. 2 , method 500 may include a first step 501 inwhich the manufacturer 37 creates an mHealth application 1 for adisease. The application 1 may be any set of instructions for executionby an electronic device 19 having a processor and memory. Examples ofthe electronic device 19 may include a mobile device, a computer, apersonal digital assistant, a tablet, a medical device (e.g., an insulinpen, a patch, an implantable or ingestible chip, or any other suitableelectronic device). The healthcare provider 7 (e.g., primary carephysician, specialist, or any other medical professional withprescribing authority) may prescribe the mHealth application 1 to thepatient 8, at step 502. The patient 8 then may use the mHealthapplication 1 to manage a disease at step 503.

As shown in FIG. 3 , step 501 in FIG. 1 may include several sub steps.For example, at step 526, the manufacturer 37 (e.g. a pharmaceuticalcompany) may implement software development 12 for the mHealthapplication 1 for a disease 2. The manufacturer 37 also may acquire anational drug code 18 number at step 527, for example from a regulatoryentity, such as the Food and Drug Administration. At step 528, themanufacturer 37 may acquire a national provider identifier 13 so thathealthcare provider 7 can electronically denote the service as aprescription to the patient 8. The manufacturer 37 may enlist a healthinsurance company 17 to use the mHealth application 1 as an availabletreatment for the patient 8 at step 529.

Referring now to FIG. 4 , step 526 shown in FIG. 3 may further includeseveral sub steps collectively referred to as method 550. For example,at step 551, the manufacturer 37 may electronically automaticallyanalyze the nature of the disease 2. In addition, the manufacturer 37may devise and implement a plan or design for the software 6, at step552. The manufacturer 37 may implement the programming 28 of thesoftware 6, at step 553. At step 554, the manufacturer 37 may test thesoftware 6 and at step 555, the manufacturer 37 may deploy the software6. The manufacturer 37 also may engage in maintenance, updating, and bugfixing of the software 6, at step 556.

FIG. 5 shows sub steps of step 502 shown in FIG. 1 as method 575. Instep 576, the healthcare provider 7 may electronically send the mHealthapplication 1 prescription information to the patient 8 via the network32. The manufacturer 37 may be informed of the prescription of themHealth application 1 at step 577 via any suitable manner, e.g., email,updating an online database, etc. A third party business 35 may beinformed of the prescription of the mHealth application 1 by thehealthcare provider 7 or patient 8 at step 578. At step 579, the thirdparty business 35 may fill the prescription for mHealth application 1 byproviding the patient 8 an activation code 15 or other suitable meansknown in the art.

Referring now to FIG. 11 , step 576 of method 575 may include sub stepscollectively referred to as method 600. For example, at step 601 thehealthcare provider 7 may send the mHealth application 1 acquisitioninformation to a patient 8. At step 602, the healthcare provider 7 mayinstruct the patient 8 to retrieve an activation code 15 for the mHealthapplication 1 at a third party business 35, such as pharmacy, healthcareclinic, laboratory, or any other suitable location.

Method 625 as shown in FIG. 12 shows sub steps of step 577. For example,method 625 includes a step 626 in which the patient 8 may provideidentifying information 11 for an mHealth support system 23. At step627, the patient 8 may provide information about their electronic device19 to the mHealth support system 23. At step 628, the healthcareprovider 7 may provide an electronic medical record 14 of the patient 8to an mHealth support system 23 affiliated with the manufacturer 37,which may create an electronic personal medical profile 21 of patient 8.

As shown in FIG. 6 , step 628 may include sub steps collectivelyreferred to as method 650. For example, step 651 may include parsing theelectronic medical record 14 into the patient data based on a program33. At step 652, the personal medical profile 21 may be created bycomparison of the patient data to an existing template patient profile22 with a profile-creating program 20. At step 653, the personal medicalprofile 21 and patient data may be stored in a database 30 for referenceand modification during mHealth application 1 usage.

FIG. 7 shows sub steps of step 503 shown in FIG. 2 . The sub steps ofstep 503 are collectively referred to as method 675. The steps mayinclude the patient 8 acquiring the mHealth application 1 on thepatient's electronic device 19 via a computer network 32, such as theInternet at step 676. The patient 8 may use the activation code 15received from the manufacturer 37 to activate the mHealth application 1at step 677. At step 678, the patient 8 may learn how to use the mHealthapplication 1 via instructional information received from the patient'selectronic device 19 connected to the network 32. The instructionalinformation may be in any suitable form. For example, a text message(SMS or any other form), video tutorial, slide show, animation, or anyother manner. At step 679, the patient 8 may interact with the mHealthapplication 1 using their electronic device 19 to manage their disease2. At step 680, the manufacturer 37 may monitor the use of the mHealthapplication 1 by the patient 8 by sending and receiving data from thepatient's electronic device 19.

FIG. 8 shows method 700 showing sub steps of step 678. For example, atstep 701, the mHealth support system 23 may be notified when the mHealthapplication 1 is activated. Further, the mHealth support system 23 mayschedule an in person visit or any other meeting (e.g., via phone orvideo conference, etc.,) with the patient 8 for demonstrating,instructing, and/or verifying proper usage of the mHealth application 1,at step 702. The patient 8 may be visited or otherwise contacted by anapplication trainer 24 who may teach the patient 8 how to use themHealth application 1, at step 703. The patient 8 subsequently may useonline support 25 for additional training if needed, at step 704.

Step 679 shown in FIG. 6 may have several sub steps shown in FIG. 9 asmethod 725. For example, step 726 may include a patient 8 entering datainto the mHealth application 1 related to disease 2 on a regular orotherwise periodic basis. At step 727, the mHealth application 1, whichmay use a client server model 34, may send data through a computernetwork 32, which may then be analyzed on the server side 31 andprocessed in order to monitor the health of the patient 8 relative tothe disease 2. At step 728, patient 8 may receive feedback on themHealth application 1 by communication through the network 32.

FIG. 10 shows sub steps of step 727 as method 750. Method 750 includessub step 751 of the mHealth application 1 sending data to the server 29,and at step 752 the program 33 processes the data and compares the datato the existing personal medical profile 21. Step 753 includes examiningdata and the personal medical profile 21 to assess whether anintervention 27 is warranted. At step 754, if an intervention 27 orgeneral feedback is warranted, information may be sent to the patient 8,caregiver or healthcare provider as needed. The personal medical profile21 may further be tailored to the patient at step 755 by using programs33 having machine learning algorithms 26. The newly modified personalmedical profile 21 may be stored in a database 30 for future access andreference, at step 756.

FIG. 13 shows method 775, which includes sub steps of step 680. Thesteps included in method 775 may include step 776 of the manufacturer 37billing the health insurance company 17 through the third party business35 if the patient 8 uses the mHealth application 1 successfully. Step777 includes the manufacturer 37 ensuring the patient's compliance andoutcomes and reporting compliance to the insurance company 17, ifrequired.

The disclosure comprises numerous terms that may be necessary to definethe scope for purposes of interpretation. The definition of these termsallows numerous embodiments that may arise, rather than just thepreferred embodiment. The terms are as follows: the mHealth application1, disease 2, chronic disease 3, software development 12, the computernetwork 32, software 6, healthcare provider 7, patient 8, pharmacypractice 9, pharmacy 10, identifying information 11, national provideridentifier 13, electronic medical record 14, activation code 15,pharmaceutical company 16, health insurance company 17, national drugcode 18, electronic device 19, profile creating program 20, personalmedical profile 21, template patient profile 22, mHealth support system23, application trainer 24, online support 25, machine learning 26,intervention 27, programming 28, server 29, database 30, server side 31,computer network 32, program 33, client server model 34, third partybusiness 35, retail store 36, and the manufacturer 37.

The term mHealth application 1 is broadly thought to include, but notlimited to, an application on an electronic device 19, for use withmedicine and public health. Some embodiments may use an mHealth diseaseand epidemic outbreak tracing/tracking application 38, an mHealtheducation application 39, an mHealth diagnostic and treatment supportapplication 40, a mHealth communication and training for healthcareworkers application 41, an mHealth remote monitoring application 42, oran mHealth remote data collection application 43 instead of the mHealthapplication 1. The term disease 2 is thought to encompass, but is notlimited to, a medical condition associated with specific symptoms andsigns which may also be a chronic disease 3. The term chronic disease 3is thought to encompass, but is not limited to, a human health conditionor disease that is persistent or otherwise long lasting in its effects(when the course of the disease lasts for, e.g., more than threemonths). In some embodiments the chronic disease may include (but is notlimited to) Diabetes, Asthma, Cancer, Mental illness, COPD and/orHypertension. In most embodiments, it is thought that the healthcareprovider 7 may be a doctor 65; however, it is possible that in thefuture an advanced practice registered nurse 66, physician's assistant67, or any other suitable healthcare professional could fill this role.The term patient 8 is thought to encompass, but is not limited to, arecipient of health care services. In some embodiments, one cancontemplate that the patient 8 also may be an inpatient 68, anoutpatient 69, a health care consumer 70, a health consumer 71, or anassisted living resident 72.

The term software development 12 is thought to encompass, but is notlimited to, the activity of computer programming, which is the processof writing and maintaining the source code and includes all that isinvolved between the conception of the desired software through to thefinal manifestation of the software in a planned and structured process.The term computer network 32 is broadly thought to include, but is notlimited to, a telecommunications network that allows computers toexchange data. In some versions, functionally, the computer network 32could be either a personal area network 120, a wireless personal areanetwork 121, a near-me area network 122, a local area network 123, awireless local area network 124, a wireless mesh network 125, a wirelessmetropolitan area network 126, a wireless wide area network 127, acellular network 128, a home area network 129, a storage area network130, a campus area network 131, a backbone area network 132, ametropolitan area network 133, a wide area network 134, an enterpriseprivate network 135, a virtual private network 136, an intranet 137, acloud network, a social network, an extranet 138, a Internetwork 139, oran Internet 140. The term software 6 is thought to encompass acollection of computer programs and related data.

In other embodiments, not just the preferred, the term third partybusiness 35 may include, but is not limited to, a company or businessconcern other than the manufacturer 37, patient 8, healthcare provider 7or health insurance company 17 that bills for services and refills themHealth application 1. In some embodiments, this may be a pharmacy 10 ora retail store 36. One or more pharmacies, retail stores, insurancecompanies, and/or physicians may access interconnected servers forsending and retrieving data related to one or more patient. The mHealthapplication 1 may process the requests and exchange of patientinformation/data, and may regulate the dispensing of pharmaceuticals,medical therapies, medical devices, or other suitable healthcare relatedproducts based on access to patient data.

The drug or other prescribed medical product may only be refilled if(e.g. the pharmacy (e.g., third party business, etc.,) receivesnotification regarding authorization to refill) per the application, itis determined that the patient has used all or a pre-determined amountof the originally prescribed amount of medical product or therapy. Inthis manner waste, fraud, and/or off-label use of medical products ortherapy may be deterred or avoided. Further, the disclosed methods maydetermine a minimum effective dose or amount of a medicalproduct/therapy, thereby further reducing waste and healthcare relatedcosts as well as avoiding potential side effects, increasedde-sensitivity and other potential harms involved with overuse of drugs.

Moreover, the disclosed methods may improve patient compliance withhealthcare professional recommendations and treatment plans by providingpatients with frequent and real-time information regarding the patient'streatment and effectiveness of the treatment plan. In addition, theinterconnectivity of healthcare provider, pharmacy, user application,and other entities may provide improved and quicker access, feedback,and treatment for patients while reducing waste and healthcare costs.

The term manufacturer 37 is thought to encompass, but is not limited to,a person or business concern that creates the mHealth application 1. Insome embodiments, manufacturer 37 may include a pharmaceutical company16. The term retail store 36 is thought to encompass a store thatpractices the sale of goods and services from individuals or business toa consumer. For examples, a retail store 36 may purchase goods orproducts in large quantities from manufacturers directly or through awholesaler, and then sell or resell smaller quantities to the consumerfor a profit. The term pharmacy practice 9 is broadly thought to includea practice linking the safe and effective use of pharmaceutical drugs tothe practice of the health sciences. The term pharmacy 10 is thought toencompass, but is not limited to, an establishment where pharmacypractice 9 is performed. Alternatively, in other embodiments, thepharmacy 10 may be a community pharmacy 73, a retail pharmacy 74, ahospital or internal pharmacy 75, a clinical pharmacy 76, an ambulatorycare pharmacy 77, a compounding pharmacy 78, a consultant pharmacy 79,an internet pharmacy 80, a nuclear pharmacy 81, or a military pharmacy82. The term pharmaceutical company 16 is thought to encompass a companywho develops produces, and markets, devices, therapies, drugs, and/orpharmaceuticals for use in managing disease 2. The term health insurancecompany 17 is broadly thought to include a company in the business ofissuing insurance against the risk of incurring medical expenses amongindividuals.

The term identifying information 11 is broadly thought to include, butis not limited to, information that can be used on its own or with otherinformation to identify, contact, or locate a single person, or toidentify an individual in context. In some versions, the identifyinginformation 11 could be a name, finger print, retina scan, DNAsignature, voice profile, biometric profile, email address or user ID,date of birth, home telephone number, cellular telephone number, homeaddress, work address, age, gender, country, or state or other location.An alert may be provided to the healthcare provider, manufacturer, orany other relevant entity, via the network 32, if an unauthorized useris attempting to use the medical product or access the application in anunauthorized manner. The alert may have any suitable form, such as anSMS message, phone voice message, email message, etc.

The term national provider identifier 13 is broadly thought to include,but is not limited to, a National Provider Identifier or NPI, which is aunique 10-digit identification number issued to healthcare providers inthe United States by the Centers for Medicare and Medicaid Services(CMS). The term electronic medical record 14 is broadly thought toinclude electronic health information and may be a representation of alla patients' health related information data that would be typicallyfound in the traditional paper-based records. The term national drugcode 18 may include a unique 10-digit, 3-segment numeric identifierassigned to each medication listed under Section 510 of the US FederalFood, Drug, and Cosmetic Act.

The term computer memory 95 is broadly thought to include the physicaldevices used to store programs (sequences of instructions) or data(e.g., program state information) on a temporary or permanent basis foruse in a computer or other digital electronic device. In someembodiments, it is thought that the electronic device 19 also may be adesktop computer, a car information service, a game console, a laptop, anotebook, a palmtop, a tablet, a smartphone, or a smart book. Theelectronic device 19 may include four or more components respectivelydefined as the computer central processing unit (CPU), the computermemory, the computer operating system 96, and the computer graphicaluser interface. The term computer operating system 96 is thought toencompass, but is not limited to, a collection of software that managescomputer hardware resources and provides common services for computerprograms. The term computer graphical user interface may include a typeof user interface that allows users to interact with electronic devicesthrough graphical icons and visual indicators such as secondarynotation, as opposed to text-based interfaces, typed command labels ortext navigation. The term profile-creating program 20 is thought toencompass a program 33 that creates intervention 27 related parametersbased on incoming data from a patient 8. The term personal medicalprofile 21 is broadly thought to include, but is not limited to, a modelgenerated from a machine learning algorithm 26 based on patient datathat has been collected over time. The term template patient profile 22may include a model generated from a machine learning algorithm 26 basedon primary patient data and general knowledge of how the data parametersindicate health or illness as reported by the patient over time.

In one or more other embodiments, the term mHealth support system 23 mayinclude, but is not limited to, a system with a range of patientservices to assist patients in the correct use of a mHealth application1. It includes assistance in planning, installation, training,troubleshooting, maintenance, compatibility, and upgrading of themHealth application 1. The mHealth support system 23 may or may not beaffiliated with the manufacturer 37. The term application trainer 24 isthought to encompass a person knowledgeable of the disease 2 and themHealth application 1 who assists the patient 8 in learning its uses.The term online support 25 is thought to encompass support structuresthat provide on-line libraries and tools for self-help and easytroubleshooting solutions to automatically and precisely diagnose andresolve problems and incidents. Alternatively, the online support 25 maybe self-support automation or also assisted support automation in someembodiments. The term intervention 27 is broadly thought to include anattempt by the mHealth application 1 to notify one or more entitiese.g., the patient 8, healthcare provider 7, or caregiver of apresumptive problem with the management of the disease 2.

In other embodiments, not just the preferred, the term programming 28may include the comprehensive process that leads from an originalformulation of a computing problem to executable programs. The termserver 29 is thought to encompass a system (software and suitablecomputer hardware) that responds to requests across a computer network.The term database 30 is thought to encompass an organized collection ofdata with a software system designed to allow the definition, creation,querying, update, and administration of databases. The term server side31 may include operations that are performed by the server in aclient—server relationship in computer networking.

In other embodiments, not just the preferred, the term program 33 mayinclude a sequence of instructions, written to perform a specified taskwith a computer that is executed by the computer central processing unit94. The term client server model 34 may include structure in computingthat partitions tasks or workloads between the providers of a resourceor service, called servers, and service requesters, called clients. Theterm machine-learning algorithm 26 is broadly thought to include aseries of systems or programs that can learn from data without having tobe explicitly programmed e.g. a neural network.

Alternatively, in other embodiments, the machine learning may be adecision tree learning 109, an association rule learning 110, anartificial neural networks 111, an inductive logic programming 112, asupport vector machines 113, a clustering 114, a Bayesian networks 115,a reinforcement learning 116, a representation learning 117, asimilarity and metric learning 118, or a sparse Dictionary Learning 119.

FIG. 14 provides a functional block diagram illustration ofgeneral-purpose computer hardware platforms. FIG. 14 illustrates anetwork or host computer platform 900, as typically may be used toimplement a server, such as the server 29. It is believed that thoseskilled in the art are familiar with the structure, programming, andgeneral operation of such computer equipment and as a result, thedrawings should be self-explanatory.

A platform for a server or the like 900, for example, may include a datacommunication interface for packet data communication 960. The platformalso may include a central processing unit (CPU) 920, in the form of oneor more processors, for executing program instructions. The platformtypically includes an internal communication bus 910, program storage,and data storage for various data files to be processed and/orcommunicated by the platform such as ROM 930 and RAM 940, although theserver 900 often receives programming and data via networkcommunications 970. The hardware elements, operating systems, andprogramming languages of such equipment are conventional in nature, andit is presumed that those skilled in the art are adequately familiartherewith. The server 900 also may include input and output ports 950 toconnect with input and output devices such as keyboards, mice,touchscreens, monitors, displays, etc. Of course, the various serverfunctions may be implemented in a distributed fashion on a number ofsimilar platforms, to distribute the processing load. Alternatively, theservers may be implemented by appropriate programming of one computerhardware platform.

Program aspects of the technology may be thought of as “products” or“articles of manufacture” typically in the form of executable codeand/or associated data that is carried on or embodied in a type ofmachine-readable medium. “Storage” type media include any or all of thetangible memory of the computers, processors or the like, or associatedmodules thereof, such as various semiconductor memories, tape drives,disk drives and the like, which may provide non-transitory storage atany time for the software programming. All or portions of the softwaremay at times be communicated through the Internet or various othertelecommunication networks. Such communications, for example, may enableloading of the software from one computer or processor into another, forexample, from a management server or host computer of the mobilecommunication network into the computer platform of a server and/or froma server to the mobile device. Thus, another type of media that may bearthe software elements includes optical, electrical and electromagneticwaves, such as used across physical interfaces between local devices,through wired and optical landline networks and over various air-links.The physical elements that carry such waves, such as wired or wirelesslinks, optical links, or the like, also may be considered as mediabearing the software. As used herein, unless restricted tonon-transitory, tangible “storage” media, terms such as computer ormachine “readable medium” refer to any medium that participates inproviding instructions to a processor for execution.

The many features and advantages of the disclosure are apparent from thedetailed specification, and thus, it is intended by the appended claimsto cover all such features and advantages of the disclosure which fallwithin the true spirit and scope of the disclosure. Further, sincenumerous modifications and variations will readily occur to thoseskilled in the art, it is not desired to limit the disclosure to theexact construction and operation illustrated and described, andaccordingly, all suitable modifications and equivalents may be resortedto, falling within the scope of the disclosure.

Other embodiments of the disclosure will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

What is claimed is:
 1. A computer-implemented method for providing andmonitoring user compliance with a regimen over a network, the methodcomprising: analyzing properties of a disease based on patient data,wherein the properties of the disease comprise symptoms and treatmentsassociated with the disease; generating a user personal medical profilebased on receiving patient identification information and an electronicmedical record of the patient, wherein the user personal medical profileis further based on comparing user data from the electronic medicalrecord to one or more existing template patient profiles, and whereinthe user personal medical profile is generated based on a modelgenerated from a machine learning algorithm, wherein the machinelearning algorithm includes one or more of a decision tree learningalgorithm, an association rule learning algorithm, an artificial neuralnetwork, an inductive logic programming algorithm, a support vectormachines based algorithm, a clustering algorithm, a Bayesian networksalgorithm, a reinforcement learning algorithm, a representation learningalgorithm, a similarity and metric learning algorithm, or a sparsedictionary learning algorithm; storing the user personal medicalprofile, wherein the stored personal medical profile is accessed by anapplication for use and wherein the stored personal medical profile isupdated by the application; generating the application for operation ona user device having a graphical user interface (GUI), the applicationincluding an input for the user to input data via the GUI for use inevaluating compliance with the regimen, wherein the user device is oneof a desktop computer, a game console, a laptop, a notebook, a palmtop,a tablet, a smartphone, or a smart book; providing instructionalinformation via the user device, the instructional information includinginstructions for use of the application and being provided via one ormore of a text message, a video tutorial, a slide show, and ananimation; receiving patient entries input via the GUI, over thenetwork; analyzing patient entries for compliance with the regimen basedon the patient entries, wherein analyzing the patient entries comprisescomparing the patient entries to the user personal medical profile todetermine that one or more of a change or an action is needed; providingfeedback, via the application, to the patient, based on analyzing thepatient entries; processing a request for one or more healthcareproducts via the application, wherein the one or more healthcareproducts may be selected from a pharmaceutical, a medical therapy, or amedical device; activating the application based on receiving, over thenetwork, an instruction to activate the application from a complianceentity; automatically updating the application based on the patiententries; determining unauthorized use of the application based on one ormore of an unauthorized user, an unauthorized device, or an unauthorizeduse; generating an alert, via the network, based on determining theunauthorized use of the application and providing the alert to theprovider; sending, via the network, a report to the provider, based onanalyzing the patient entries; receiving user compliance data from theapplication over the network based on the patient entries; andgenerating electronic feedback to the user based on electronicprocessing of the user compliance data.
 2. The computer-implementedmethod of claim 1, further comprising acquiring a national drug codenumber from a regulatory entity.
 3. The computer-implemented method ofclaim 2, further comprising generating a software based on analyzing theproperties of the disease.
 4. The computer-implemented method of claim3, acquiring a national provider identifier (NPI), wherein anapplication based on the software is prescribed, via a prescription froma health care provider, based on at least one of the national drug codenumber and the NPI.
 5. The computer-implemented method of claim 1,further comprising: receiving, over the network, instructions for theregimen; and providing a report to the compliance entity based onanalyzing the patient entries, wherein the report comprises an analysisof patient compliance with the regimen, and wherein the complianceentity is an insurance company.
 6. A system for providing and monitoringcompliance with a regimen over a network, the system comprising: a datastorage device storing instructions for causing computer servers anduser devices to generate, provide, or evaluate compliance with, theregimen; and a processing device configured to execute instructions toperform a method of: analyzing properties of a disease based on patientdata, wherein the properties of the disease comprise symptoms andtreatments associated with the disease; generating a user personalmedical profile based on receiving patient identification informationand an electronic medical record of the patient, wherein the userpersonal medical profile is further based on comparing user data fromthe electronic medical record to one or more existing template patientprofiles, and wherein the user personal medical profile is generatedbased on a model generated from a machine learning algorithm; storingthe user personal medical profile, wherein the stored personal medicalprofile is accessed by an application for use and wherein the storedpersonal medical profile is updated by the application; generating theapplication for operation on a user device having a graphical userinterface (GUI), the application including an input for the user toinput data via the GUI for use in evaluating compliance with theregimen; receiving patient entries input via the GUI, over the network;analyzing patient entries for compliance with the regimen based on thepatient entries, wherein analyzing the patient entries comprisescomparing the patient entries to the user personal medical profile todetermine that one or more of a change or an action is needed;processing a request for one or more healthcare products via theapplication, wherein the one or more healthcare products may be selectedfrom a pharmaceutical, a medical therapy, or a medical device; providinga report to a compliance entity based on analyzing the patient entries,wherein the report comprises an analysis of patient compliance with theregimen; activating the application based on receiving, over thenetwork, instructions from the compliance entity; and receiving usercompliance data from the application over the network based on thepatient entries.
 7. The system of claim 6, wherein the processing deviceis further configured to execute instructions to provide, via thenetwork, a notification to a dispenser to refill a prescription for theapplication based on analyzing the patient entries.
 8. The system ofclaim 6, wherein the compliance entity is an insurance company.
 9. Thesystem of claim 6, wherein the processing device is further configuredto execute instructions to send, via the network, a report to the user,based on analyzing the patient entries.
 10. The system of claim 6,wherein the processing device is further configured to executeinstructions to automatically update the application based on thepatient entries.
 11. The system of claim 6, wherein the processingdevice is further configured to receive, over the network, instructionsfor the regimen.
 12. The system of claim 6, further comprisinggenerating a software based on analyzing the properties of the disease.13. The system of claim 12, further comprising acquiring a national drugcode number from a regulatory entity.
 14. The system of claim 13,further comprising acquiring a national provider identifier (NPI),wherein an application based on the software is prescribed, via aprescription from a health care provider based on at least one of thenational drug code number and the NPI.
 15. A non-transitorycomputer-readable medium storing instructions that, when executed by aprocessor, cause the processor to provide and monitor compliance with aregimen over a network, the instructions comprising: analyzingproperties of a disease based on patient data, wherein the properties ofthe disease comprise symptoms and treatments associated with thedisease; generating a user personal medical profile based on receivingpatient identification information and an electronic medical record ofthe patient, wherein the user personal medical profile is further basedon comparing user data from the electronic medical record to one or moreexisting template patient profiles, and wherein the user personalmedical profile is generated based on a model generated from a machinelearning algorithm; storing the user personal medical profile, whereinthe stored personal medical profile is accessed by an application foruse and wherein the stored personal medical profile is updated by theapplication; generating the application for operation on a user devicehaving a graphical user interface (GUI), the application including aninput for the user to input data via the GUI for use in evaluatingcompliance with the regimen; providing instructional information via theuser device, the instructional information including instructions foruse of the application and being provided via one or more of a textmessage, a video tutorial, a slide show, and an animation; receivingpatient entries input via the GUI, over the network; analyzing patiententries for compliance with the regimen based on the patient entries,wherein analyzing the patient entries comprises comparing the patiententries to the user personal medical profile to determine that one ormore of a change or an action is needed; processing a request for one ormore healthcare products via the application, wherein the one or morehealthcare products may be selected from a pharmaceutical, a medicaltherapy, or a medical device; providing a report to a compliance entitybased on analyzing the patient entries, wherein the report comprises ananalysis of patient compliance with the regimen; activating theapplication based on receiving, over the network, instructions from thecompliance entity; and receiving user compliance data from theapplication over the network based on the patient entries.
 16. Thenon-transitory computer-readable medium of claim 15, further comprisinggenerating a software based on analyzing the properties of the disease.17. The non-transitory computer-readable medium of claim 16, furthercomprising acquiring a national drug code number from a regulatoryentity.
 18. The non-transitory computer-readable medium of claim 17,further comprising acquiring a national provider identifier (NPI),wherein the application based on the software is prescribed, via aprescription from a health care provider, based on at least one of thenational drug code number and the NPI.
 19. The non-transitorycomputer-readable medium of claim 15, wherein the processor is furtherconfigured to execute instructions to automatically update theapplication based on the patient entries.
 20. The non-transitorycomputer-readable medium of claim 15, wherein the processor is furtherconfigured to receive, over the network, instructions for the regimen.